Intranasal Injection of Dexmedetomidine and Bupivacaine in Septoplasty Surgeries

Phase 4

• Conditions: Intranasal Dexmedetomidine; Intranasal Bupivacaine; Septoplasty Surgeries
• Interventions: Drug: Dexmedetomidine; Drug: Bupivacaine

• Registration Number: NCT03926663
• Lead Sponsor: Cairo University

Brief Summary

Pain is particularly common after nasal surgery, especially when bone manipulation and periosteal irritation are involved. Appropriate pain control is an important consideration in the post-surgical management of patients.

Detailed Description

Multiple researches and clinical observations suggest that pain reduction can be achieved in nasal surgery by using local anesthesia.The combination of local anesthetic infiltration, directly in the surgical field, with general anesthesia provides beneficial analgesic effects by blocking nociceptive pathways, and there by it reduces the need for systemic analgesics.

The use of α-2 Adrenergic receptor (adrenoceptor) agonists in anesthesia were the focus of interest for their sedative, analgesic, and perioperative sympatholytic and cardiovascular stabilizing effects with reduced anesthetic requirements. α-2 agonists, inhibit substance P release in the nociceptive pathway at the level of the dorsal root neuron; in addition, α-2 adrenergic receptors located at nerve endings may have a role in the analgesic effect of the drug by preventing norepinephrine release.

In this study, the combined effects of dexmedetomidine with bupivacaine as local anesthetics vs bupivacaine, will be investigated in septoplasty to determine the need for rescue drugs as propanlol and nitroglycerine, as hypotensive agents,for bloodless surgical field and optimal procedure for pain control

Study Timeline

• Study First Submitted: 2019-04-22
• Study First Submitted QC: 2019-04-22
• Study First Posted: 2019-04-24
• Status Verified: 2019-07
• Study Start: 2019-07-20
• Last Update Submitted: 2019-07-30
• Last Update Posted: 2019-08-01
• Primary Completion: 2019-09
• Study Completion: 2019-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patients aged from 18- 60 years
• ASA physical status I
• Undergoing septoplasty

Exclusion Criteria

• Patients with cardiovascular disease (congestive heart failure, coronary artery disease, hypertension.
• History of renal or hepatic insufficiency
• Endocrinal Diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group Bupivacaine +Dexmedetomidine	Bupivacaine	group B+D; will receive 0.25% bupivacaine (with an average dose of 1-1.5 mg/kg) + 0.2 μg/kg dexmedetomidine preincisional local infiltration of the nasal mucosa of the nasal septum,injected once before surgical intervention.
group Bupivacaine	Bupivacaine	Group B; will receive 0.25% bupivacaine (with an average dose of 1-1.5 mg/kg) as preincisional local infiltration of the nasal mucosa of the nasal septum ,injected once before surgical intervention
group Bupivacaine +Dexmedetomidine	Dexmedetomidine	group B+D; will receive 0.25% bupivacaine (with an average dose of 1-1.5 mg/kg) + 0.2 μg/kg dexmedetomidine preincisional local infiltration of the nasal mucosa of the nasal septum,injected once before surgical intervention.

Primary Outcome Measures

Name	Time	Method
The precentage of patients that will take rescue drugs as nitroglycerin, propranolol.	3 hours	the number of patients that will need rescue drugs: propranolol 1mg will be given then after 15 minutes (with no improvement of the surgical field) nitroglycerin (NTG) infusion will be added in a titrated manner 0.1-0.5 μg/kg/min gradually till the target MAP (±60 mmHg) is reached.

Trial Locations

Locations (1)

Faculty of medicine,Beni-Suef University; 🇪🇬 Banī Suwayf, Egypt